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 Arimidex
Pharmaceutical form
'Arimidex' is presented as white, biconvex, film-coated tablets containing 1
mg of anastrozole. A logo is impressed on one side and a tablet strength
marking on the other side.
Therapeutic Indication
Adjuvant treatment of postmenopausal women with hormone receptor positive
early breast cancer.
Treatment of advanced breast cancer in post-menopausal women. Efficacy has
not been demonstrated in oestrogen receptor negative patients unless they
had a previous positive clinical response to tamoxifen.
Dosage and method of administration
Adults including the elderly : One 1mg tablet to be taken orally once a day
Children : Not recommended for use in children
Renal Impairment : No dose change is recommended in patients with mild or
moderate renal impairment
Hepatic Impairment : No dose change is recommended in patients with mild
hepatic disease.
For early disease, the recommended duration of treatment should be 5 years.
Contraindications
'Arimidex' is contra-indicated in:
-
pre-menopausal women.
- pregnant or lactating women.
-
patients with severe renal impairment (creatinine clearance less than
20ml/min).
-
patients with moderate or severe hepatic disease.
-
patients with known hypersensitivity to anastrozole or to any of the
excipients as referenced in the list of excipients.
Oestrogen-containing therapies should not be co-administered with 'Arimidex'
as they would negate its pharmacological action
Concurrent tamoxifen therapy (see Interaction).
Special Warning and Special Precautions for Use
'Arimidex' is not
recommended for use in children as safety and efficacy have not been
established in this group of patients.
The menopause should be defined biochemically in any patient where there is
doubt about hormonal status.
There are no data to support the safe use of Arimidex' in patients with
moderate or severe hepatic impairment, or patients with severe impairment of
renal function (creatinine clearance less than 20ml/min).
As 'Arimidex' lowers circulating oestrogen levels it may cause a reduction
in bone mineral density with a possible consequent increased risk of
fractures.
Interaction with other medicinal products and other forms of interaction
Antipyrine and cimetidine clinical interaction studies indicate that the
co-administration of 'Arimidex' with other drugs is unlikely to result in
clinically significant drug interactions mediated by cytochrome P450.
A review of the clinical trial safety database did not reveal evidence of
clinically significant interaction in patients treated with 'Arimidex' who
also received other commonly prescribed drugs.
There is no clinical information to date on the use of Arimidex' in
combination with other anti-cancer agents
Oestrogen-containing therapies should not be co-administered with 'Arimidex'
as they would negate its pharmacological action.
Tamoxifen should not be co-administered with 'Arimidex' as this may diminish
its pharmacological action
Pregnancy and Lactation
'Arimidex' is contra-indicated in pregnant or lactating women.
Effects on Ability to Drive and Use Machines
'Arimidex' is unlikely to impair the ability of patients to drive and
operate machinery. However, asthenia and somnolence have been reported with
the use of 'Arimidex' and caution should be observed when driving or
operating machinery while such symptoms persist.
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